It is well known by now that counterfeit medicines can be extremely dangerous and a tremendous health risk for patients. It is one of the biggest battles Pharma companies continue to face irrespective of their location and size. The measures that the industry took was to put in place track and trace laws which ensures that products are regulated and passed safely as well as responsibility through the entire supply chain. The requirements do differ depending on the country however, these drug related concerns were introduced and agreed upon by more than 40 countries across the globe. The legislations in place aim to always protect patients through goods having corresponding serial numbers that can help with the tracking of them.
Getting an organization completely serialized can have initial challenges such as costs, labor, training, etc. Each product within the business must have unique information that can allow easy identification and can be looked up and referred to at any time. This of course, means there are large volumes of data that must be maintained and available for data exchange within systems as well as be fully integrated with respective CMOs.
The information per unit must allow for supply chain visibility and verification, recall, and disposition information. Serialization allows connectivity with supply chain partners especially when integrated with the technological requirements that allows easily available data and can lead to safer patient care.
With Serialization there are changing requirements and regular updates passed by regulating bodies so it’s essential that all businesses stay compliant. Organizations must strategies, plan and prepare accordingly. The needs and demands of the markets are also in constant change so businesses should also take into account:
● The number of markets they’ll cater their products to, along with the number of products they’ll need
● Supply chain management
● Systems within the company that need to be incorporated
● The requirements and specifications as well as time constraints in those markets,
● Packaging and distribution of products
● CMO and role related concerns
● Staff resource allocation for this and their availability.